NCT05916872

Brief Summary

To determine the combined effects of proprioceptive neuromuscular facilitation and electrical muscle stimulation on spasticity and hand function in stroke patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

October 27, 2023

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

June 14, 2023

Last Update Submit

October 26, 2023

Conditions

Keywords

StrokeProprioceptive DisordersBalance; Distorted

Outcome Measures

Primary Outcomes (2)

  • Modified Barthel Index:

    It is used for assessing the activities of daily living. It is composed of 10 questions that link the degree of independence to daily living activities. Collin et, al; proposed amendment in 1988, in which each domain was scored in one-point increments, ranging from 0 to 2 or 3 for each activity with a maximum score of 20 suggesting functional independence. It is highly reliable and has a good correlation with other disability measures.

    9 months

  • Modified Ashworth Scale:

    Modified Ashworth Scale: It is used to assess the spasticity in patients of stroke or spinal cord injury. Scores range from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity. It is characterized by exaggerated deep tendon reflexes that interfere with muscular activity, gait, movement, or speech. It has excellent validity and reliability.

    9 months

Study Arms (2)

experimental group

EXPERIMENTAL

patients in this group will receive contract relax exercises along with EMS

Other: experimental group

control group

ACTIVE COMPARATOR

patients in groups B will receive conventional therapy.

Other: control group

Interventions

Patients will receive Proprioceptive Neuromuscular Facilitation (contract-relax) technique with EMS

experimental group

Patients will receive conventional therapy.

control group

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both ischemic and haemorrhagic stroke patients
  • Chronic stroke patients from 6 month to 2years
  • Mini Mental Scale Examination (MMSE) more than 25

You may not qualify if:

  • Transient ischemic attack
  • Recurrent stroke
  • Stroke patient with comorbidity and cardiac disease
  • Myopathies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, Fedral, 44000, Pakistan

Location

Related Publications (3)

  • Hankey GJ. The global and regional burden of stroke. Lancet Glob Health. 2013 Nov;1(5):e239-40. doi: 10.1016/S2214-109X(13)70095-0. Epub 2013 Oct 24. No abstract available.

    PMID: 25104481BACKGROUND
  • Faghri PD, Rodgers MM, Glaser RM, Bors JG, Ho C, Akuthota P. The effects of functional electrical stimulation on shoulder subluxation, arm function recovery, and shoulder pain in hemiplegic stroke patients. Arch Phys Med Rehabil. 1994 Jan;75(1):73-9.

    PMID: 8291967BACKGROUND
  • Rong W, Tong KY, Hu XL, Ho SK. Effects of electromyography-driven robot-aided hand training with neuromuscular electrical stimulation on hand control performance after chronic stroke. Disabil Rehabil Assist Technol. 2015 Mar;10(2):149-59. doi: 10.3109/17483107.2013.873491. Epub 2013 Dec 31.

    PMID: 24377757BACKGROUND

MeSH Terms

Conditions

StrokeSomatosensory Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Zeest Hashmi, MSNMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: patients will be allocated to two groups by randomization. Patients in Group A will receive Proprioceptive Neuromuscular Facilitation (contract-relax) technique \& EMS patients in Group B will receive conventional therapy.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2023

First Posted

June 23, 2023

Study Start

November 1, 2022

Primary Completion

September 1, 2023

Study Completion

September 15, 2023

Last Updated

October 27, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations